Safety and Efficacy Study of LIPO-202 for the Reduction o... | NCT02568319

Studies
Safety and Efficacy Study of LIPO-202 for the Reduction of Central Abdominal Bulging in Obese Subjects

NCT02568319

Sponsor

Neothetics, Inc

Status

Completed

Last Update Posted

Dec 24, 2015Estimated

Enrollment

120Estimated

Phase

Phase 2

Conditions

Central Abdominal Bulging

Interventions

LIPO-202
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Not provided

First Submitted Date

Oct 2, 2015

First Submission Date that Met QC Criteria

Oct 2, 2015

First Posted Date

Oct 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2015

Last Update Posted Date

Dec 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a multi-center, randomized, placebo-controlled, double-blind study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging in obese subjects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LIPO-202	Experimental	Experimental arm	Drug: LIPO-202
Placebo	Placebo Comparator	Placebo comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LIPO-202	Drug		LIPO-202	Salmeterol
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety as measured by physical examination, adverse events, vital signs, and laboratory tests.	Physical examination, adverse events, vital signs, and laboratory tests.	9 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in waist circumference.		9 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male or non-pregnant female subjects
Capable of providing written consent
BMI > 30 kg/m2 but < 40 kg/m2
Stable diet and exercise routine
At least "Slightly Dissatisfied" with their abdominal bulging on the Abdominal Contour Questionnaire (ACQ)

Exclusion Criteria:

BMI > 40 kg/m2
Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen.
Plan on starting a weight loss or exercise program during the study
Known hypersensitivity to study drugs
Have any medical condition that might complicate study procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Feldman	Neothetics, Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diagnamics, Inc.		Encinitas	California	92024	United States
Ablon Skin Institute and Research Center

Intervention Browse Module

MeSH Terms

ID	Term
D000068299	Salmeterol Xinafoate

Ancestor Terms

ID	Term
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930

Browse Leaves

Not provided

Browse Branches

Not provided